Gastrointestinal Physiological Conditions in Obesity and After Bariatric Surgery
NCT ID: NCT03783052
Last Updated: 2022-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2018-02-01
2021-03-30
Brief Summary
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Detailed Description
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* Healthy volunteers: Gastrointestinal physiology will be analyzed during two visits using a telemetric capsule. During the first visit, the physiological conditions of interest will be analysed in fasted state using the telemetric capsule. During the second visit, the physiological conditions of interest will be analysed in fed state using the telemetric capsule.
* Obese volunteers: Gastrointestinal physiology will be analyzed during two visits using a telemetric capsule. During the first visit, the physiological conditions of interest will be analysed in fasted state using the telemetric capsule. During the second visit, the physiological conditions of interest will be analysed in fed state using the telemetric capsule.
* Obese volunteers: Gastrointestinal physiology will be analyzed during three visits using a telemetric capsule, scintigraphy and via the collection of gastrointestinal samples. During the first visit, the physiological conditions of interest will be analysed in fasted state using the telemetric capsule. During the second visit, gastrointestinal samples will be collected at the level of the stomach, the duodenum and jejunum via aspiration through multiple lumen catheters in fasted and fed state. During the third visit, gastric emptying will be observed via scintigraphy in fed state.
* Volunteers after Sleeve Gastrectomy: Gastrointestinal physiology will be analyzed during three visits using a telemetric capsule, scintigraphy and via the collection of gastrointestinal samples. During the first visit, the physiological conditions of interest will be analysed in fasted state using the telemetric capsule. During the second visit, gastrointestinal samples will be collected at the level of the sleeve, the duodenum and jejunum via aspiration through multiple lumen catheters in fasted and fed state. During the third visit, gastric emptying will be observed via scintigraphy in fed state.
* Volunteers after Roux-en-Y gastric Bypass: Gastrointestinal physiology will be analyzed during three visits using a telemetric capsule, scintigraphy and via the collection of gastrointestinal samples. During the first visit, the physiological conditions of interest will be analysed in fasted state using the telemetric capsule. During the second visit, gastrointestinal samples will be collected at the level of the pouch, the Roux limb and the common limb via aspiration through multiple lumen catheters in fasted and fed state. During the third visit, gastric emptying will be observed via scintigraphy in fed state.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Healthy volunteers
11 Healthy volunteers
SmartPill in fasted state
SmartPill administration in fasted state
SmartPill in fed state
SmartPill administration in fed state
Obese volunteers
11 Obese Volunteers
SmartPill in fasted state
SmartPill administration in fasted state
SmartPill in fed state
SmartPill administration in fed state
Roux-en-Y Gastric Bypass patients
6 volunteers with a Roux-en-Y Gastric Bypass
SmartPill in fasted state
SmartPill administration in fasted state
Aspiration
Aspiration of gastrointestinal samples in fasted and fed state
Gastric emptying scintigraphy
Gastric emptying scintigraphy in fed state
Sleeve Gastrectomy patients
6 volunteers with a Sleeve Gastrectomy
SmartPill in fasted state
SmartPill administration in fasted state
Aspiration
Aspiration of gastrointestinal samples in fasted and fed state
Gastric emptying scintigraphy
Gastric emptying scintigraphy in fed state
Volunteers with obesity
6 obese volunteers
SmartPill in fasted state
SmartPill administration in fasted state
Aspiration
Aspiration of gastrointestinal samples in fasted and fed state
Gastric emptying scintigraphy
Gastric emptying scintigraphy in fed state
Interventions
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SmartPill in fasted state
SmartPill administration in fasted state
SmartPill in fed state
SmartPill administration in fed state
Aspiration
Aspiration of gastrointestinal samples in fasted and fed state
Gastric emptying scintigraphy
Gastric emptying scintigraphy in fed state
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Disorders of swallowing
* Suspected strictures, fistulas or physiological GI obstruction.
* GI surgery within past three months
* Severe dysphagia to food or pills
* Crohns disease or diverticulitis
* Use of implanted or portable electro-mechanical medical devices
* Known intolerance to the SmartPill device
* Known food allergies to any component of the meal
* History of multiple bariatric surgeries
* Pregnant or lactating women
18 Years
ALL
Yes
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Bart Van der Schueren, PhD
Role: PRINCIPAL_INVESTIGATOR
UZ Leuven, Department of Endocrinology
Locations
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UZ Leuven
Leuven, , Belgium
Countries
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Other Identifiers
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S60930
Identifier Type: -
Identifier Source: org_study_id
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